Clinical Glossary) RJ Cliniminds Bhopal

8/9/2019 Clinical Glossary) RJ Cliniminds Bhopal

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A glossary is an alphabetical list of terms in a particular domain of knowledge with the

definitions for those terms. Traditionally, a glossary appears at the end of a book and includes

terms within that book which are either newly introduced or at least uncommon.

A bilingual glossary is a list of terms in one language which are defined in a second language

or glossed by synonyms (or at least near-synonyms) in another language.

In a general sense, a glossary contains explanations of concepts relevant to a certain field of

study or action. In this sense, the term is related to the notion of ontology. Automatic

methods have been also provided that transform a glossary into ontology or a computational

lexicon.Basic research

Done in the laboratory, basic research involves studying how cells work, how they

communicate, how they know what to do, and what conditions and drugs make their

functions more or less efficient. Scientists who conduct basic research test new treatments in

animals to find out if they might be helpful or harmful to people.

Clinical research

Treatments with the most promising laboratory results move from laboratory and animal

studies into the clinical trial stage. In clinical trials, scientists apply their discoveries to

humans, testing new drugs, devices, or innovative therapies in selected patients. Carefully

conducted clinical trials are the safest way to evaluate potential medical treatments, assessing

their effectiveness and potential risks.

Glossary of Clinical Trials Terms

The following glossary was prepared to help the consumer become familiar with many of the

common terms used in clinical trials.

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ABSORB/ABSORPTION: The passage of substances into or across tissues, such as thepassage of food and water from the intestines into the bloodstream. Because of a lack of

digestive enzymes, some foods eaten by people with CF may not be well absorbed and used

by the body (see DIGESTIVE SYSTEM, ENZYMES, PANCREAS, INTESTINE and

MALABSORPTION).

ADVERSE DRUG REACTION (ADR): In the pre-approval clinical experience with a new

medicinal product or its new usages, particularly as the therapeutic dose(s) may not be

established: all noxious and unintended responses to a medicinal product related to any dose

should be considered adverse drug reactions. The phrase responses to a medicinal product

means that a causal relationship between a medicinal product and an adverse event is at least

a reasonable possibility, i.e. the relationship cannot be ruled out.

Regarding marketed medicinal products: a response to a drug which is noxious and

unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or

therapy of diseases or for modification of physiological function (see the ICH Guideline for

Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

ADVERSE REACTION: (Adverse Event.) An unwanted effect caused by the

administration of drugs. Onset may be sudden or develop over time (See Side Effects).

ADVOCACY AND SUPPORT GROUPS: Organizations and groups that actively support

participants and their families with valuable resources, including self-empowerment and

survival tools.

AEROSOLIZED: A liquid substance released as a spray.

AIRWAYS: Tubes that bring outside air into the lungs. The lungs have many airways of

varied sizes. The largest is the trachea between the throat and the lungs. It branches into

smaller airways in the lungs called bronchi. These divide into still smaller branches called

bronchioles. These turn into alveoli, the very smallest airways.

ALVEOLI: A tiny, thin-walled, capillary rich sac in the lungs where exchange of oxygen

and carbon dioxide takes place. Singular: Alveolus.

AMENDMENT (to the protocol): See Protocol Amendment.


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AMINOGLYCOSIDES: A group of antibiotics used to treat bacterial infections.

Tobramycin and gentamicin are examples of aminoglycosides used in CF treatment (see

ANTIBIOTIC and BACTERIA).

ANTIBIOTIC: A drug that kills bacteria or slows bacterial growth. Antibiotics are oftenused to treat lung infections (see AMINOGLYCOSIDES, BACTERIA and

CEPHALOSPORINS).

ANTI-INFLAMMATORY AGENT: Medication to reduce inflammation or irritation of

body tissue. Ibuprofen is an example of an anti-inflammatory agent used in CF treatment.

ANTIBODY: molecule in the body that combines with a foreign bacteria or virus to stop its

activity or signal other molecules in the body to become active in fighting the foreign germ.

ANTIMICROBIAL: Can stop the growth of disease-causing germs.

APPLIWAL REGULATORY REQUIREMENT: Anylaw(s) and regulation(s) addressing

the conduct of clinical trials of investigational products.

APPROWAL (in relation to Institutional Review Boards): The affirmative decision of the

IRB that the clinical trial has been reviewed and may be conducted at the institution site

within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and

the applicable regulatory requirements.

APPROVED DRUGS: In the U.S., the Food and Drug Administration (FDA) must approve

a substance as a drug before it can be marketed. The approval process involves several steps

including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy,

filing of a New Drug Application by the manufacturer of the drug, FDA review of the

application, and FDA approval/rejection of application (See Food and Drug Administration).

ARM: Any of the treatment groups in a randomized trial. Most randomized trials have two

"arms," but some have three "arms," or even more (See Randomized Trial).

ASSAY: A way to measure how many parts of a certain ingredient are in a larger system,

object or mixture.

AUDIT: A systematic and independent examination of trial related activities and documents

to determine whether the evaluated trial related activities were conducted, and the data were

recorded, analyzed and accurately reported according to the protocol, sponsor's standard

operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory

requirement(s).

AUDIT CARTIFICATE: A declaration of confirmation by the auditor that an audit has

taken place.


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AUDIT REPORT: A written evaluation by the sponsor's auditor of the results of the audit.

AUDIT TRAIL: Documentation that allows reconstruction of the course of events.

AUTOSOMAL RECESSIVE: A genetic trait or disorder that appears only when a person

inherits a pair of chromosomes, each of which has the gene for the trait. One chromosome ofthe pair comes from the father and the other from the mother. Autosomal recessive disorders

occur only if each parent is either a carrier of the trait or has the trait. CF is an autosomal

recessive disease (see CARRIER and GENE).


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BACTERIA: Tiny one-celled creatures that are often the cause of infections. People with CFare prone to bacterial lung infections (often caused by the bacteria Staphylococcus aureus and

Pseudomonas aeruginosa). Some bacteria normally found in the body are helpful. For

example, Escherichia coli live in the intestines and help with digestion (see ANTIBIOTIC,

INTESTINE, PSEUDOMONAS AERUGINOSA and STAPHYLOCOCCUS AUREUS).

BALANCED STUDY: When a particular type of participant (for instance, females, people

with certain lung function levels, African Americans, etc.) is equally represented in each

study group.

BASELINE: 1. Information gathered at the beginning of a study from which variations found

in the study are measured. 2. A known value or quantity with which an unknown is compared

when measured or assessed. 3. The initial time point in a clinical trial, just before a

participant starts to receive the experimental treatment which is being tested. At this reference

point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are

often determined by monitoring changes from the baseline values.

BIAS: When a point of view prevents impartial judgment on issues relating to the subject of

that point of view. In clinical studies, bias is controlled by blinding and randomization (See

Blind and Randomization).

BIOFILM: A substance that sticks to wet surfaces. Biofilms can form on solid or liquid

surfaces as well as on soft tissue in living organisms. They are usually difficult to dissolve. In

CF, a biofilm, or protective coating, is formed by Pseudomonas aeruginosa bacteria and

prevents drugs from killing the bacteria.

BIOMARKERS: A biochemical or a substance in the body that can be used to measure

disease activity or effects of treatment.

BILE: A bitter fluid produced by the liver and stored in the gallbladder. Bile is discharged

into the small intestine when needed to aid in the digestion of fats.

BILIARY FIBROSIS: A disease of the gallbladder, bile ducts, and bile characterized by the

replacement of normal tissue with fibrous tissue and loss of functional cells.

BLIND: A randomized trial is "Blind" if the participant is not told which arm of the trial he is

on. A clinical trial is "Blind" if participants are unaware on whether they are in the


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experimental or control arm of the study; also called masked. (See Single Blind Study and

Double Blind Study).

BLINDING/MASKING: A procedure in which one or more parties to the trial are kept

unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) beingunaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in

some cases, data analyst(s) being unaware of the treatment assignment(s).

BMI (Body Mass Index): A measurement comparing fat to muscle in the human body.

Weight in kilograms is divided by height in meters to figure out the degree of nutritional

health, such as determining malnutrition or obesity.

BROAD SPECTRUM: An antibiotic that is effective against a wide range of organisms.

BRONCHO-ALVEOLAR FLUID: Fluid found in the bronchiole and alveoli part of the

lungs.

BRONCHO-ALVEOLAR LAVAGE: A diagnostic test where fluid is taken from the

bronchioles and alveoli part of the lungs.

BRONCHOSCOPY: A procedure using a small tube (bronchoscope) to look down the throat

and inside the lungs.

BURKHOLDERIA CEPACIA COMPLEX: Bacteria that can live in the lungs of people

with CF and cause infection. This bacterium is resistant to antibiotics and easily spread

between people with CF, and can cause life-threatening lung infections.


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CADAVERIC: Having to do with a dead body (a cadaver).

CARRIER: A person having a single gene for a genetic trait or disorder like CF. Carriers

shows no signs of the disease. In CF, each parent of a child with CF either has CF or is a CF

carrier (see GENE and HEREDITARY).

CASE REPORT FROM (CRF): A printed, optical, or electronic document designed to

record all of the protocol required information to be reported to the sponsor on each trial

subject.

CELL: The basic unit of living organisms.

CEPHALOSPORINS: A group of antibiotics used to treat bacterial infections (see

ANTIBIOTIC and BACTERIA).

CFTR: see CYSTIC FIBROSIS CONDUCTANCE TRANSMEMBRANE REGULATOR

CHROMOSOME: The thread-like material that carriers genes, the units of heredity.

Chromosomes are in the nucleus of every living cell. Every person should have 23 pairs of

chromosomes in each cell.

CHRONIC: A disease or condition that lasts and is continuous. CF is a chronic disease.

CIRRHOSIS: A chronic disease of the liver characterized by the replacement of normal

tissue with fibrous tissue and the loss of functional liver cells.

CLINICAL: Related to the study and treatment of people in a medical setting or clinic.

Pertaining to or founded on observation and treatment of participants, as distinguished from

theoretical or basic science.

CLINICAL ASSESSMENT: An evaluation of the symptoms and progression of a disease.

CLINICAL INVESTIGATOR: A medical researcher, most often a medical doctor,responsible for carrying out a clinical research protocol (see PROTOCOL and PRINCIPAL

INVESTIGATOR).

CLINICAL ENDPOINT: See Endpoint.

CLINICAL STUDY: Types of researchalso called observational researchin which

participants are observed. While these studies do not use drugs or treatments, they are very

important for developing new ideas about how diseases or progression of disease could be

prevented or treated.


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CLINICAL TRIAL: A type of researchalso called interventional researchthat follows

certain government guidelines for testing the effect of drugs on people. Researchers observe

how the drug affects the body under highly controlled conditions and whether the treatment is

helpful.A clinical trial is a research study to answer specific questions about vaccines or new

therapies or new ways of using known treatments. Clinical trials (also called medical research

and research studies) are used to determine whether new drugs or treatments are both safe

and effective. Carefully conducted clinical trials are the fastest and safest way to find

treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment

in a small group; Phase II expands the study to a larger group of people; Phase III expands

the study to an even larger group of people; and Phase IV takes place after the drug or

treatment has been licensed and marketed. (See Phase I, II, III, and IV Trials).

CLINICALLY STABLE: When symptoms are not changing or progressing and, for the

time being, are not expected to.

COHORT: In epidemiology, a group of individuals with some characteristics in common.

COMMUNITY-BASED CLINICAL TRIAL (CBCT): A clinical trial conducted primarily

through primary-care physicians rather than academic research facilities.

COMPARATOR (Product): An investigational or marketed product (i.e., active control), or

placebo, used as a reference in a clinical trial.

COMPASSIONATE USE: A method of providing experimental therapeutics prior to final

FDA approval for use in humans. This procedure is used with very sick individuals who have

no other treatment options. Often, case-by-case approval must be obtained from the FDA for

"compassionate use" of a drug or therapy.

COMPLEX DOSAGE REQUIREMENTS: When clinical trial participants are required to

take an experimental drug or treatment several times a day or to take a combination of drugs

and treatments.

COMPLEMENTARY AND ALTERNATIVE THERAPY: Broad range of healing

philosophies, approaches, and therapies that Western (conventional) medicine does not

commonly use to promote well-being or treat health conditions. Examples include

acupuncture, herbs, etc. Internet Address: http://www.nccam.nih.gov.

COMPLETED: See Recruitment Status

COMPLIANCE (in relation to trials): Adherence to all the trial-related requirements, Good

Clinical Practice (GCP) requirements, and the applicable regulatory requirements.


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COMPUTED TOMOGRAPHY (CT scan): A three-dimensional image or picture of the

body showing three measurements, such as height, width and depth. Created by a computer

from a series of cross-sectional pictures.

CONDENSATE: Something that has turned into liquid, such as a liquid reduced from a gasor vapor, like water from steam.

CONFIDENTIALITY: The FDA and medical ethics require that the identities and medical

information of all clinical trial participants be kept confidential. When a person joins a

clinical trial, they must agree to share their medical records with researchers. The Principal

Investigator must guarantee these records remain confidential (see FDA and PRINCIPAL

INVESTIGATOR).

CONFIDENTIALITY REGARDING TRIAL PARTICIPANTS: Refers to maintaining

the confidentiality of trial participants including their personal identity and all personal

medical information. The trial participants' consent to the use of records for data verification

purposes should be obtained prior to the trial and assurance must be given that confidentiality

will be maintained.

CONTRACT: A written, dated, and signed agreement between two or more involved parties

that sets out any arrangements on delegation and distribution of tasks and obligations and, if

appropriate, on financial matters. The protocol may serve as the basis of a contract.

CONTRAINDICATED: Used to describe when certain medicines or treatments should not

be used.

CONTRAINDICATION: A specific circumstance when the use of certain treatments could

be harmful.

CONTROL: A control is the nature of the intervention control.

CONTROL GROUP: In many clinical trials, one group of patients receives the

experimental drug or treatment, while the control group receives either a standard treatment

or placebo (see PLACEBO and STANDARD TREATMENT).

CONVENTIONAL: Following what is traditional or customary. Not new or experimental.

CONTROLLED TRIALS: Control is a standard against which experimental observations

may be evaluated. In clinical trials, one group of participants is given an experimental drug,

while another group (i.e., the control group) is given either a standard treatment for the

disease or a placebo.

COORDINATING COMMITTEE: A committee that a sponsor may organize to coordinate

the conduct of a multicentre trial.


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COORDINATING COMMITTEE: An investigator assigned the responsibility for the

coordination of investigators at different centres participating in a multicentre trial.

CONTRACT RESEARCH ORGANIZATION (CRO): A person or an organization

(commercial, academic, or other) contracted by the sponsor to perform one or more of asponsor's trial-related duties and functions.

CULTURE: Sputum or throat swab is put on a medium for germs to grow in the laboratory,

so the germ can be identified.

CYSTIC FIBROSIS CONDUCTANCE TRANSMEMBRANE REGULATOR (CFTR):

A protein in the cell that makes the channel where chloride moves in and out. The defect in

the channel causes CF.

CYSTIC FIBROSIS-RELATED DIABETES (CFRD): The bodys inability to move sugar

from the blood into the cells for energy. A special form of diabetes found in people with CF.


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DATA SAFETY AND MONITORING BOARD (DSMB): An independent committee,

composed of community representatives and clinical research experts, that reviews data while

a clinical trial is in progress to ensure that participants are not exposed to undue risk. A

DSMB may recommend that a trial be stopped if there are safety concerns or if the trial

objectives have been achieved.

DEFICIENCY: A lack of something necessary to good health. An insufficiency. Example: a

Vitamin D deficiency in people with CF.

DEHYDRATED: Remove moisture.

DETECT: To discover the existence, presence, or fact of. To uncover something that has

been hidden or is not as it should be.

DETERIORATION: The process of becoming worse. Example: when someones health

deteriorates.

DIAGNOSE: To find the cause of health problems.

DIGESTION: The process of breaking down the food we eat and absorbing its nutrients into

the body for energy (see ABSORPTION).

DIGESTIVE SYSTEM: The organs that take in digest and get rid of food. Includes the

mouth, salivary glands, pharynx (throat), esophagus, stomach, intestines, liver, pancreas,

colon, rectum and anus. In CF, thick mucus blocks some passages in the digestive system,

like that between the pancreas and intestines.

DIAGNOSTIC TRIALS: Refers to trials that are conducted to find better tests or procedures

for diagnosing a particular disease or condition. Diagnostic trials usually include people who

have signs or symptoms of the disease or condition being studied.

DIRECT ACCESS: Permission to examine, analyze, verify, and reproduce any records and

reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and

foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take

all reasonable precautions within the constraints of the applicable regulatory requirement(s)

to maintain the confidentiality of subjects' identities and sponsors proprietary information.

DOCUMENTATION: All records, in any form (including, but not limited to, written,

electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that


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describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial,

and the actions taken.

DOSAGE: The prescribed amount of a drug that must be taken to get the benefit or intended

result.DOSE-RANGING STUDY: A clinical trial in which two or more doses of an agent (such as

a drug) are tested against each other to determine which dose works best and is least harmful.

DOUBLE-BLIND STUDY: A clinical trial design in which neither the participating

individuals nor the study staff knows which participants are receiving the experimental drug

and which are receiving a placebo (or another therapy). Double-blind trials are thought to

produce objective results, since the expectations of the doctor and the participant about the

experimental drug do not affect the outcome; also called double-masked study. See Blinded

Study, Single-Blind Study, and Placebo.

DOUBLE-MASKED STUDY: See Double-Blind Study.

DRUG-DRUG INTERACTION: A modification of the effect of a drug when administered

with another drug. The effect may be an increase or a decrease in the action of either

substance, or it may be an adverse effect that is not normally associated with either drug.

DSMB: See Data Safety and Monitoring Board.

DUCT: A tube or passageway for secretions. Ducts are found in organs, such as the pancreas,

organ systems and exocrine glands. In CF, thick mucus can block these ducts (see

SECRETION).


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EFFICACY: (Of a drug or treatment). The maximum ability of a drug or treatment to

produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose

tested and against the illness for which it is prescribed. In the procedure mandated by the

FDA, Phase II clinical trials gauge efficacy and Phase III trials confirms it (See Food and

Drug Administration (FDA), Phase II and III Trials).

ELIGIBILITY CRITERIA: Summary criteria for participant selection; includes Inclusion

and Exclusion criteria. (See Inclusion/Exclusion Criteria)

EMPIRICAL: Based on experimental data, not on a theory.ENDPOINT: Overall outcome that the protocol is designed to evaluate. Common endpoints

are severe toxicity, disease progression, or death.

ENERGY INTAKE: Energy helps cells perform all of their functions, including building

proteins and other substances the body may require. Energy intake is based on food that is

eaten.

ENROLL: Joining a clinical trial, after meeting all necessary criteria and signing the

Informed Consent Form (see INCLUSION/EXCLUSION CRITERIA and INFORMED

CONSENT DOCUMENT).

ENROLLING: The act of signing up participants into a study. Generally this process

involves evaluating a participant with respect to the eligibility criteria of the study and going

through the informed consent process.

ENZYMES: Proteins that help make and increase certain chemical processes in the body,

like the breaking down of foods in digestion. Because people with CF have mucus that often

blocks the passageways (or ducts) through which digestive enzymes from the pancreas flow,

they may need enzyme replacements to digest food (see ABSORPTION, DIGESTIVE

SYSTEM, MUCUS and PANCREAS).

EPIDEMIOLOGY: The branch of medical science that deals with the study of incidence

and distribution and control of a disease in a population.

ESOPHAGUS: The tube that leads from the throat (pharynx) to the stomach.

ESSENTIAL DOCUMENTS: Documents which individually and collectively permit

evaluation of the conduct of a study and the quality of the data produced (see 8. Essential

Documents for the Conduct of a Clinical Trial).


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EXACERBATION: Signs and symptoms that show a need for treatment.

EXCLUSION/INCLUSION CRITERIA: Standards used to decide whether a person may

or may not enrol in a clinical trial. Criteria are based on such factors as age, gender, disease,

previous treatment history, and other medical conditions. These criteria are not used to keeppeople out of clinical trials, but rather to identify the right participants and keep them safe in

a trial.

EXHALATION: Breath out air.

EXPANDED ACCESS: Refers to any of the FDA procedures for distributing experimental

drugs to patients who are no longer benefiting from currently available treatments and unable

to participate in on-going clinical trials (see COMPASSIONATE USE, PARALLEL TRACK

and TREATMENT IND).

EXPERIMENTAL DRUG: A drug that is not FDA licensed for use in humans, or as a

treatment for a particular condition (See Off-Label Use).


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FAILURE TO THRIVE: Not gaining weight or growing at a normal rate.

FDA: See Food and Drug Administration.

FOOD AND DRUG ADMINISTRATION (FDA): The U.S. Department of Health and

Human Services agency responsible for ensuring the safety and effectiveness of all drugs,

biologics, vaccines, and medical devices, including those used in the diagnosis, treatment,

and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA

also works with the blood banking industry to safeguard the nation's blood supply.

FORMULATION: A prescribed recipe for making a drug.


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GASTROESOPHAGEAL REFLUX DISEASE (GERD): a condition in which food or

liquid travels backwards from the stomach to the oesophagus (the tube from the mouth to the

stomach). This action can irritate the oesophagus, causing heartburn and other symptoms.

GENE: The main unit of heredity. Each chromosome carries hundreds of genes. Genes

decide body traits like eye and hair colour, height, facial features and many health problems.

CF is caused by an alteration of a gene. A child inherits CF when two CF genes are received,

one from each parent (see AUTOSOMAL RECESSIVE, CARRIER and HEREDITARY).

GENETIC: Hereditary or inherited. Material that is passed on from parents to children (see

GENE).

GLAND: A group of cells that make substances so that other parts of the body can work. The

pancreas is a gland that makes enzymes so food can be broken down and absorbed by the

body.

GLUCOSE: A sugar.

GOOD CLINICAL PRACTICE (GCP): The standard for clinical trial design, conduct,

performance, monitoring, auditing, recording, analysing and reporting. GCP ensures that

reported results will be credible and accurate, and that the rights, integrity and confidentiality

of patients are protected.

GRAM NEGATIVE: Bacteria that does not retain the violet dye stained by Grams stain

method (method classifies bacteria as positive or negative).

GRAM POSITIVE: Bacteria that retain the violet dye when stained by Grams stain method

(method classifies bacteria as positive or negative).


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HEREDITARY: Traits or conditions, like eye colour or CF, that are genetically passed from

parents to their children (see GENE and GENETIC).

HETEROZYGOUS: Having different pairs of genes for any hereditary characteristic

HIGH-RESOLUTION COMPUTER TOMOGRAPHY (CT scan): A three-dimensional

image or picture of the body. Created by a computer from a series of cross-sectional pictures

with edge-defining qualities to sharpen the image, sometimes with a closer view of a smaller

area. A close-up CT scan. Used often to create images of a persons lungs (see COMPUTED

TOMOGRAPHY).HOMOZYGOUS: Having the same pairs of genes for any hereditary characteristic.

HORMONE: Secretion from glands. Hormones regulate body functions like growth and

heart rate.

HYDRATING: Add moisture.

HYPERGLYCEMIA: Higher than normal blood glucose or blood sugar in the bloodstream.

HYPOTHESIS: A supposition or assumption advanced as a basis for reasoning or argument,

or as a guide to experimental investigation. Theory or assumption used as a guide in clinical

research.


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IMMUNE: Resistant to infection by a specific germ.

IMPAIRED GLUCOSE TOLERANCE: A fasting blood sugar of 100 to 125 mg/dl and /or

a blood sugar of 140 to 199 mg/dL 2 hours after an oral glucose load during an oral glucose

tolerance test (OGTT).

INACTIVE (Inert): Having no effect.

IMPARTIAL WITNESS: A person, who is independent of the trial, who cannot be unfairly

influenced by people involved with the trial, who attends the informed consent process if the

subject or the subjects legally acceptable representative cannot read, and who reads theinformed consent form and any other written information supplied to the subject.

INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining

whether a person may or may not be allowed to enter a clinical trial. These criteria are based

on such factors as age, gender, the type and stage of a disease, previous treatment history, and

other medical conditions. It is important to note that inclusion and exclusion criteria are not

used to reject people personally, but rather to identify appropriate participants and keep them

safe.

IND: See INVESTIGATIONAL NEW DRUG.

INDICATION: Something that points to or suggests the proper treatment of a disease, as

required by the cause or symptoms. Like a tip-off, or clue, that certain action is required.

INDEPENDENT DATA MONITORING COMMITTEE (IDMC) (Data and Safety

Monitoring Board, Monitoring Committee, Data Monitoring Committee): An

independent data-monitoring committee that may be established by the sponsor to assess at

intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints,

and to recommend to the sponsor whether to continue, modify, or stop a trial.

INDEPENDENT ETHICE COMMITTEE (IEC): An independent body (a review board

or a committee, institutional, regional, national, or supranational), constituted of medical

professionals and non-medical members, whose responsibility it is to ensure the protection of

the rights, safety and well-being of human subjects involved in a trial and to provide public

assurance of that protection, by, among other things, reviewing and approving / providing

favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and


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the methods and material to be used in obtaining and documenting informed consent of the

trial subjects.

The legal status, composition, function, operations and regulatory requirements pertaining to

Independent Ethics Committees may differ among countries, but should allow theIndependent Ethics Committee to act in agreement with GCP as described in this guideline.

INDUCTANCE PLETHYSMOGRAPHY: A machine to measure lung volume and lung

health in people ages 6 years of age and older. Sometimes called a body box.

INFLAMMATION: The swelling of body tissues due to irritation or injury. Inflammation

occurs with an infection.

INFORMED CONSENT: The process of learning about a clinical study or trial before

deciding whether to join. Doctors and nurses involved in the trial fully explain the study and

answer any questions. The goal is to have people participate who are informed about the

study or trial.

INFORMED CONSENT DOCUMENT: A document that describes the rights of clinical

research participants and details about the study or trial. It includes the studys purpose,

length, required procedures, and staff contact information. It also explains any risks and

potential benefits. The patient should ask the study staff any questions before signing.

INHALE: To breathe in.

INHERITED: Traits or conditions, like eye colour or CF, that are genetically passed from

parents to their children (see GENE and GENETIC).

IN-PATIENT (IN-PATIENT STUDY/TRIAL): Hospitalized patient. Study or trial that

requires time in a hospital.

INSPECTION: The act by a regulatory authority(ies) of conducting an official review of

documents, facilities, records, and any other resources that are deemed by the authority(ies)

to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's

and/or contract research organizations (CRO is) facilities, or at other establishments deemed

appropriate by the regulatory authority(ies).

INSPECTION (Medical): Any public or private entity or agency or medical or dental facility

where clinical trials are conducted.

INSTITUTIONAL REVIEW BOARD (IRB): Committee of research and disease experts,

and community advocates working to ensure that a clinical trial is fair and ethical, and that

the rights of all participants are protected. All clinical trials in the United States must be

approved by an IRB before they can begin. This group approves the initial research and


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reviews the research as it progresses to help protect the rights and safety of participants. The

IRB also must approve all materials prepared for participants, including the informed consent

document, promotional posters, flyers, brochures, Web sites, and other items.

INTERIM CLINICAL TRAIL/STUDY REPORT: A report of intermediate results andtheir evaluation based on analyses performed during the course of a trial.

INTERVENTIONS: Approach to treating a disease or condition. Intervention is a word

frequently used to describe a treatment or therapy.

INTENT TO TREAT: Analysis of clinical trial results that includes all data from

participants in the groups to which they were randomized (See Randomization) even if they

never received the treatment.

INTESTINE: Tube in the digestive system that connects the stomach to the anus. The long,

narrow, upper part is the small intestine. The short, wide, lower part is the large intestine.

Also called the bowel.

INTRAMUSCULAR: In the muscle. Example: a shot or intramuscular injection.

INTRAVENOUS (IV): Putting a medicine right into a blood vessel, usually a vein, using a

thin needle and a tube.

INTERVENTION NAME: The generic name of the precise intervention being studied.

INTERVENTIONS: Primary interventions being studied: types of interventions are Drug,

Gene Transfer, Vaccine, Behavior, Device, or Procedure.

INVESTIGATIONAL NEW DRUG (IND): A new drug, antibiotic drug, or biological drug

that is used in a clinical investigation. It also includes a biological product used in vitro for

diagnostic purposes.

An experimental drug that is approved by the FDA for use in clinical trials.

INVASTIGATIONA PRODUCT: A pharmaceutical form of an active ingredient or

placebo being tested or used as a reference in a clinical trial, including a product with a

marketing authorization when used or assembled (formulated or packaged) in a way different

from the approved form, or when used for an unapproved indication, or when used to gain

further information about an approved use.

INVESTIGATIONAL TREATMENT: An unapproved treatment, or a treatment used for a

new purpose in clinical research. This is usually a drug.

INVASTIGRATOR: A person responsible for the conduct of the clinical trial at a trial site.

If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible

leader of the team and may be called the principal investigator. See also Subinvestigator.


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INVASTIGRATOR / INSTITUTION: An expression meaning "the investigator and/or

institution, where required by the applicable regulatory requirements".

INVASTIGRATOR BROCHURE: A compilation of the clinical and nonclinical data on the

investigational product(s) which is relevant to the study of the investigational product(s) inhuman subjects (see 7. Investigators Brochure).

IN VITRO: Latin for in glass. Usually refers to research in a laboratory, outside the body.

IN VIVO: Latin for in living (body). Usually refers to research done in living animals and

humans.


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LEGALLY ACCEPTABLE REPRESTATIVE: An individual or juridical or other body

authorized under applicable law to consent, on behalf of a prospective subject, to the subject's

participation in the clinical trial.

LIVING DONOR: A living person who donates a body part for transplantation into another

person. Many different types of organs can come from living donors, like a kidney, or a lobe

of a lung or liver.

LIVING SYSTEMS: Human, animal, or cell environments used for experimental purposes

in clinical trials (see IN VITRO and IN VIVO).

LOBAR: A well-defined part of an organ or gland. The lungs have several distinct lobes.

LUPUS: Any of several diseases, which first affect the skin and joints, but often involve

other parts of the body.


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MACROLIDES: A group of antibiotics used to treat lung infections, including azithromycin

and erythromycin.

MALABSORPTION: Poor uptake of nutrients from food for use by the body. In CF, mucus

may plug ducts of digestive organs and block the secretion of enzymes and hormones. This

makes many nutrients unavailable for use in body maintenance and growth (see

ABSORPTION, DIGESTION, DIGESTIVE SYSTEM, DUCT, ENZYME, FAILURE TO

THRIVE, HORMONE, MUCUS, ORGAN, PANCREAS and SECRETION).

MASKED: The knowledge of intervention assignment. See Blind

MARKERS: A substance in the body that, when present in large or abnormal amounts,

suggests the presence of disease. Also called a biomarker.

MICROBIOLOGY: The branch of biology that deals with microorganisms and their effects

on other living organisms. The study of microscopic forms of life (such as bacteria, viruses,

and fungi).

MICROORGANISMS: A form of life that can be seen under a microscope. Germs are

microorganisms.

MODELS: Represents a living system and used in research.

MONITORING: The act of overseeing the progress of a clinical trial, and of ensuring that it

is conducted, recorded, and reported in accordance with the protocol, Standard Operating

Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory

requirement(s).

MONITORING REPORT:A written report from the monitor to the sponsor after each site

visit and/or other trial-related communication according to the sponsors SOPs.MUCOCILIARY CLEARANCE: In the airways of the lungs, this system works to move

mucus and particles breathed in to upper airways so they can be coughed out of the lungs.

MUCOID: Resembling mucus; forming large moist sticky colonies of bacteria.

MUCOSAL: A fluid made by mucous membranes and glands. Normally thin and slippery.

In CF, mucus is thick and sticky.

MUCUS: A fluid made by membranes and glands. Mucus is normally thin and slippery. In

CF, the mucus is often thick and sticky (see GLAND, MUCUS MEMBRANE, PHLEGM

and SPUTUM).


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MUCUS MEMBRANE: Tissue that contains mucus-making glands. Mucus membranes are

found in the nose, mouth, lungs, esophagus, stomach, and intestines (see ESOPHAGUS,

GLAND, INTESTINE, MUCUS and TISSUE).

MULTI-CENTER: More than one medical or research institution, such as a multi-centerclinical study.

MUTATION: A change in a gene (sees AUTOSOMAL RECESSIVE, CARRIER,

CHROMOSOME, and GENE, GENETIC, HEREDITARY and INHERITED).


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NATURAL HISTORY STUDY: Study of the natural development of something (such as an

organism or a disease) over a period of time.

NATIONAL INSTITUTES OF HEALTH (NIH): The agency of the U.S. Department of

Health and Human Services (DHHS) responsible for health and medical research. NIH

conducts research in its own laboratories and funds billions of dollars in research at other

facilities, including universities, in the United States and abroad.

NEUTROPHIL: A white blood cell that destroys foreign bacteria in the body.NEW DRUG APPLICATION (NDA): An application for a new drug submitted to the FDA

to review and approve an experimental drug. The application is submitted after the

completion of clinical trials and before a drug can be available to the general public.

NONCLINICAL STUDY:Biomedical studies not performed on human subjects.

NONINVASIVE: Not penetrating the body, as by incision. Used to describe a diagnostic

procedure that does not invade healthy tissue.

NOVEL TECHNIQUE: A newly used skill or procedure.

NSAIDS: Non Steroidal Anti-Inflammatory Drugs, such as ibuprofen and aspirin (see ANTI-

INFLAMMATORY AGENT).


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OBSTRUCTED: To block, make difficult to pass.

OFF-LABEL USE: When a drug is prescribed for conditions other than those approved by

the FDA.

OPEN-LABEL TRIAL: A clinical trial where all parties, including physicians and

participants, know if they are using an investigational drug. Also when all participants get to

receive the investigational drug once its safety and effectiveness have been established and

before the FDA approves it.

OPINION (in relation to Independent Ethics Committee): The judgement and/or the

advice provided by an Independent Ethics Committee (IEC).

ORAL: Taken by mouth.

ORAL GLUCOSE TOLERANCE TEST (OGTT): This test is used to diagnose not just

diabetes and CFRD but also the varied types of abnormal glucose tolerance in CF. You must

first fast (nothing to eat or drink) for 12 hours. Then, blood is drawn to measure your

baseline or fasting glucose level. You are then asked to drink glucose. Your blood sugar

is measured again 2 hours later. Often, blood sugar is measured at 1, 2, and 3 hours later.

ORGAN: A part of the body that performs a specific function or group of functions. Some

common organs are the heart, lungs, and brain. A group of related organs is an organ system,

such as the digestive system.

ORGANISM: A form of life, such as a plant, animal, bacterium (single bacteria) or fungus.

ORIGINAL MEDICAL RECORD: See Source Documents.

ORPHAN DRUGS: An FDA category that refers to medications used to treat diseases and

conditions that occur rarely. There is little financial incentive for the pharmaceutical industry

to develop medications for these diseases or conditions. Orphan drug status, however, gives a

manufacturer specific financial incentive to develop and provide such medications.

OSCILLOMETRY: Measurement of changes, used in studying cardiovascular and

respiratory functions.

OUTCOME: Overall results of a study or trial offered up for evaluation. Also called an

endpoint.

OXIDANT: A substance that oxidizes another substance.OXIDIZES: To combine with oxygen.


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PANCREAS: A long organ with glands found behind the stomach. The pancreas secretes

enzymes through ducts into the intestine to break down food. In CF, mucus may obstruct the

pancreatic ducts, preventing digestion. Another part of the pancreas has endocrine tissue,

which makes a hormone called insulin. Insulin controls storage and use of sugar (see

ENZYMES and MUCUS).

PANCREATIC INSUFFICIENCY (PI): The failure to properly digest food due to a lack of

digestive enzymes made by the pancreas.PARALLEL TRACK TRIAL: A system of making experimental drugs available to

individuals who are unable to participate in clinical trials.

PARAMETER: Used to measure the quantity or function of something. Example: FEV1 is a

measurement, or parameter, for lung function.

PEER REVIEW: Review of a clinical trial by experts chosen by the study sponsor. These

experts review the trials for scientific merit, participant safety, and ethical considerations.

PFTs: See PULMONARY FUNCTION TESTS.

PHARMACOKINETICS: The processes (in a living organism) of absorption, distribution,

metabolism, and excretion of a drug or vaccine.

PHASE I TRIALS: First step in drug development to test a drugs safety and to find out how

the human body reacts to the drug. The purpose of Phase 1 trials is to discover the side effects

of increased doses and collect early evidence of drug effectiveness. Healthy volunteers or

people, who do not have the disease or condition being studied, are often included.

PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of

the drug for a particular indication or indications in patients with the disease or condition

under study and to determine the common short-term side effects and risks.

PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary

evidence suggesting effectiveness of the drug has been obtained, and are intended to gather

additional information to evaluate the overall benefit-risk relationship of the drug and provide

and adequate basis for physician labeling.

Usually the last type of clinical trial before a drug is approved by the FDA. Intended to gather

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1) The general risk-benefit of the drug, and

2) How to administer the drug (see RISK-BENEFIT).

PHASE IV TRIALS: Research conducted after FDA approval to get additional information

about the drugs long-term risks, benefits, and best possible use.PHLEGM: Mucus made from glands in the airways of the lung.

PLACEBO: A placebo is an inactive pill, liquid, or powder that has no treatment value. In

clinical trials, experimental treatments are often compared with placebos to assess the

treatment's effectiveness. (See Placebo Controlled Study).

PLACEBO CONTROLLED STUDY: A method of investigation of drugs in which an

inactive substance (the placebo) is given to one group of participants, while the drug being

tested is given to another group. The results obtained in the two groups are then compared to

see if the investigational treatment is more effective in treating the condition.

PLACEBO EFFECT: A physical or emotional change, occurring after a substance is taken

or administered, that is not the result of any special property of the substance. The change

may be beneficial, reflecting the expectations of the participant and, often, the expectations of

the person giving the substance.

PNEUMONIA: An inflammation of the lungs often caused by a bacterial or viral infection.

Pneumonia is a problem in people with CF.

POLYMERASE CHAIN REACTION (PCR): A laboratory technique for quickly fusing

large amounts of DNA together from a single DNA segment.

PORCINE: Of or derived from pigs.

PRECLINICAL: Testing of experimental drugs in the test tube or in animals. Occurs before

clinical trials in humans are done.

PREVENTION TRIALS or STUDIES: Refers to trials to find better ways to prevent

disease in people who have never had the disease or to prevent a disease from returning.

These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

PRINCIPAL INVESTIGATOR (PI): Person responsible for the conduct of the clinical trial

at a research site.

PROCEDURE: Something done to fix a health problem or learn more about it. For example,

surgery, tests and putting in an IV (intravenous line) are procedures.

PROTEIN: Proteins are a basic part of all living cells. Found in foods such as meat, proteins

are essential in the diet for growth and repair of tissue.


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PROTOCOL: A study plan on which all clinical trials are based. The plan is carefully

designed to safeguard the health of the participants as well as answer specific research

questions. A protocol describes what types of people may participate in the trial; the schedule

of tests, procedures, medications, and dosages; and the length of the study. While in a clinicaltrial, participants following a protocol are seen regularly by the research staff to monitor their

health and to determine the safety and effectiveness of their treatment (See

Inclusion/Exclusion Criteria).

A detailed plan for a clinical trial. It describes what types of people may participate in the

trial; the schedule of tests, procedures, medications and dosages; and the length of the study.

PROTOCOL AMENDMENT: A written description of a change(s) to or formal

clarification of a protocol.

PSEUDOMONAS AERUGINOSA: A type of bacteria that often lives in the lungs of

people with CF and causes lung infections (see ANTIBIOTIC, BACTERIA and

STAPHYLOCOCCUS AUREUS).

PULMONARY: Relating to the lungs.

PULMONARY FUNCTION TESTS (PFTs): Tests to check lung function. Along with the

patients history and physical exam, PFTs help doctors diagnose a health problem, and decide

what therapy to prescribe. They can be used with children five years and older. PFTs measure

air flow and lung volumes.


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QUALITY ASSURANCE (QA): All those planned and systematic actions that are

established to ensure that the trial is performed and the data are generated, documented

(recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable

regulatory requirement(s).

QUALITY CONTROL (QC): The operational techniques and activities undertaken within

the quality assurance system to verify that the requirements for quality of the trial-related

activities have been fulfilled.

QUALITY OF LIFE TRIALS (or Supportive Care trials): Refers to trials that explore

ways to improve comfort and quality of life for individuals with a chronic illness.


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RANDOMIZATION: A method based on chance by which study participants are assigned

to a treatment group. Randomization minimizes the differences among groups by equally

distributing people with particular characteristics among all the trial arms. The researchers do

not know which treatment is better. From what is known at the time, any one of the

treatments chosen could be of benefit to the participant (See Arm).

RANDOMIZED TRIAL: A study in which participants are randomly (i.e., by chance)

assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are

utilized. (See Arm and Placebo).RECRUITING: The period during which a trial is attempting to identify and enroll

participants. Recruitment activites can include advertising and other ways of solicting interest

from possible particpants. (See recruitment status and enrolling).

RECRUITMENT STATUS: Indicates the current stage of a trial, whether it is planned,

ongoing, or completed. Possible values include:

Not yet recruiting: participants are not yet being recruited or enrolled

Recruiting: participants are currently being recruited and enrolled

Enrolling by invitation: participants are being (or will be) selected from a predetermined

population

Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but

enrollment has completed

Completed: the study has concluded normally; participants are no longer being examined or

treated (i.e., last patient's last visit has occurred)

Suspended: recruiting or enrolling participants has halted prematurely but potentially will

resume

Terminated: recruiting or enrolling participants has halted prematurely and will not resume;

participants are no longer being examined or treated

Withdrawn: study halted prematurely, prior to enrollment of first participant

RECRUITMENT: Act of enrolling people in a clinical trial.

RECRUITMENT PERIOD: Time frame allowed recruiting for a clinical trial.

REGULATATORY AUTHORITIES: Bodies having the power to regulate. In the ICH

GCP guideline the expression Regulatory Authorities includes the authorities that review


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submitted clinical data and those that conduct inspections (see 1.29). These bodies are

sometimes referred to as competent authorities.

REPRODUCIBLE: To make a counterpart, image, or copy. To produce again or a new. To

re-create. In clinical research, it refers to the ability of one study to recreate the results of adifferent study, thereby showing that the results are valid.

RESEARCH:

Applied Research

Studies that apply basic research findings to problems like diseases and symptoms.

Examples: creating new respiratory equipment or studying cell defects in the sweat glands of

people with CF (see CELL and GLAND).

Basic Science Research

Studies that increase knowledge of basic life processes. To learn the causes of CF, scientists

do basic science studies like gene studies and research on how cells work (see CELL, GENE

and GENETIC).

Clinical Research

Studies in people that improve diagnosis and treatment. Examples: studies on drugs, lung

function, nutrition, and sweating. (see DIAGNOSE, PULMONARY FUNCTION TESTS and

SWEAT TEST).

RESEARCH COORDINATOR: A staff person chosen by the principal investigator to

assist him/her in conducting the clinical trial (see PRINCIPAL INVESTIGATOR).

RESISTANCE: The ability of an organism to defend itself, either from disease or from

being harmed. Example: bacteria can become resistant to antibiotics and no longer be killed

by the drugs.

RISK-BENEFIT RATIO: The risk to individual participants versus the potential benefits.

The risk/benefit ratio may differ depending on the condition being treated.


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SAFETY: The condition or state of being safe. In clinical trials, this refers to an absence of

harmful side effects resulting from use of the product and may be assessed by special tests

and procedures, psychiatric evaluation, and/or physical examination of participants.

SAFETY PROFILE: A summary of clinical data that explains the possible side effects of a

certain drug or treatment.

SCREENING: Identifying a potential clinical trial participant by finding out if the person

meets the eligibility criteria (see ELIGIBILITY CRITERIA).

SCREENING STUDIES: Refers to studies that test how to identify diseases or conditions.

SCREENING TRIALS: Refers to trials which test the best way to detect certain diseases or

health conditions.

SECRETION: A product of a gland, like sweat or saliva (see GLAND).

SERIOUS ADERSE EVENT( SAE) OR SERIOUS ADVERSE DRUG

REACTION(Serious ADR): Any untoward medical occurrence that at any dose: results in

death, is life-threatening, requires inpatient hospitalization or prolongation of existing

hospitalization, results in persistent or significant disability/incapacity, or is a congenital

anomaly/birth defect (see the ICH Guideline for Clinical Safety Data Management:

Definitions and Standards for Expedited Reporting).

SENSITIVE: Responsive to a stimulus. Easily irritated or inflamed.

SIDE EFFECTS: Any undesired actions or effects of a drug or treatment. Negative or

adverse effects may include headache, nausea, hair loss, skin irritation, or other physical

problems. Experimental drugs must be evaluated for both immediate and long-term sideeffects (See Adverse Reaction).

SINGLE-BLIND STUDY: A study in which one party, either the investigator or participant,

is unaware of what medication the participant is taking; also called single-masked study. (See

Blind and Double-Blind Study).

SINGLE-MASKED STUDY: See Single-Blind Study.

SOURCE DATA: All information in original records and certified copies of original records

of clinical findings, observations, or other activities in a clinical trial necessary for the


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reconstruction and evaluation of the trial. Source data are contained in source documents

(original records or certified copies).

SOURCE DOCUMENT: Original documents, data, and records (e.g., hospital records,

clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluationchecklists, pharmacy dispensing records, recorded data from automated instruments, copies

or transcriptions certified after verification as being accurate copies, microfiches,

photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept

at the pharmacy, at the laboratories and at medico-technical departments involved in the

clinical trial).

SPACER DEVICE: A hollow chamber that fits on the mouthpiece of a metered dose

inhaler. It makes the inhaler easier to use and more efficient in delivering medicine.

SPIROMETER: A device that measures air flow and lung volumes (see PULMONARY

FUNCTION TESTS).

SPONSOR: Individual, company, institution or organization responsible for initiation,

management and financing of a study.

SPONSOR INVASTIGATOR: An individual who both initiates and conducts, alone or with

others, a clinical trial, and under whose immediate direction the investigational product is

administered to, dispensed to, or used by a subject. The term does not include any person

other than an individual (e.g., it does not include a corporation or an agency). The obligations

of a sponsor-investigator include both those of a sponsor and those of an investigator.

SPUTUM: Mucus or phlegm coughed up from lungs (see MUCUS and PHLEGM).

SPUTUM CULTURE: A test to see what germs may be growing in the sputum (see

SPUTUM).

SPUTUM DENSITY: A measurement of mucus or phlegm coughed up from lungs.

STANDARD OPERATING PROCEDURES (SOPs):Detailed, written instructions to

achieve uniformity of the performance of a specific function.

STANDARD TREATMENT: An effective treatment or drug approved by the FDA for a

specific disease or condition.

STANDARD TREATMENT: A treatment currently in wide use and approved by the FDA,

considered to be effective in the treatment of a specific disease or condition.

STANDARDS OF CARE: Treatment regimen or medical management based on state of the

art participant care.


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STAPHYLOCOCCUS AUREUS (STAPH): A type of bacteria that can cause infections. In

CF, staph often causes lung infections. It is treated with antibiotics (see ANTIBIOTIC and

BACTERIA).

STATISTICAL SIGNIFICANCE: The probability that an event or difference occurred bychance alone. In clinical trials, the level of statistical significance depends on the number of

participants studied and the observations made, as well as the magnitude of differences

observed.

STUDY ENDPOINT: A primary or secondary outcome used to judge the effectiveness of a

treatment.

STUDY TYPE: The primary investigative techniques used in an observational protocol;

types are Purpose, Duration, Selection, and Timing.

SUB-STUDY: A smaller study that is part of a larger study.

SUBINVESTIGATOR: Any individual member of the clinical trial team designated and

supervised by the investigator at a trial site to perform critical trial-related procedures and/or

to make important trial-related decisions (e.g., associates, residents, research fellows). See

also Investigator.

SUBJECT/TRAIL SUBJECT: An individual who participates in a clinical trial, either as a

recipient of the investigational product(s) or as a control.

SUBJECT IDENTIFICATION CODE: A unique identifier assigned by the investigator to

each trial subject to protect the subject's identity and used in lieu of the subject's name when

the investigator reports adverse events and/or other trial related data.

SURFACTANT: A chemical that can reduce the surface tension of a liquid in which it is

dissolved so that it spreads out more easily.

SUSCEPTIBILITY: Being prone to, sensitive to, or lacking the ability to resist something.

SUSPENDED: See Recruitment Status

SWEAT TEST: A test to diagnose CF. Measures the salt (sodium and chloride) in sweat.

SYSTEMIC: Affecting the body as a whole.


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UNDUE OR UNNECESSARY RISK: IRBs review clinical trial protocols to ensure

participants are not required to do anything that would be harmful to their health (see

INSTITUTIONAL REVIEW BOARDS).

UNEXPECTED ADVERSE DRUG REACTION: An adverse reaction, the nature or

severity of which is not consistent with the applicable product information (e.g.,

Investigator's Brochure for an unapproved investigational product or package insert/summary

of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety

Data Management: Definitions and Standards for Expedited Reporting).


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VALIDATE: To confirm or make true. To give official sanction or approval. In clinical

trials, it is the process by which the correctness of data are established.

VIRUS: An organism, smaller than bacteria, that causes infections like influenza, viral

pneumonia, colds, and hepatitis (see BACTERIA and PNEUMONIA).

VULNERABLE SUBJECTS: Individuals whose willingness to volunteer in a clinical trial

may be unduly influenced by the expectation, whether justified or not, of benefits associated

with participation, or of a retaliatory response from senior members of a hierarchy in case of

refusal to participate. Examples are members of a group with a hierarchical structure, such as

medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory

personnel, employees of the pharmaceutical industry, members of the armed forces, and

persons kept in detention. Other vulnerable subjects include patients with incurable diseases,

persons in nursing homes, unemployed or impoverished persons, patients in emergency

situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those

incapable of giving consent.


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WASHOUT PERIOD: A time during a clinical trial when participants receive no drugs for

the study so the effects of previous study drugs are removed.

WELL-BEING (of the trial subjects): The physical and mental integrity of the subjects

participating in a clinical trial.

WITHDRAW: The point at which a clinical trial participant, for any reason, stops

participating in the trial.

RUCHIR JAIN

M.Sc. Medical Biochemistry

PGDCTM (Cliniminds Bhopal)


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